[ref. p79581524] Regulatory Pharmacist

Job Description & Requirements

Key Responsibilities :

• Assist in preparing and submitting regulatory filings and documentation for pharmaceutical drugs.
• Support investigation of regulatory compliance gaps with gap remediation plan development and implementation thereafter.
• Determine regulatory relevance and perform variation assessments.
• Maintain and update regulatory files and records as required.
• Ensures compliance with local regulations, corporate policies, and procedures
• Collaborate with cross-functional overseas teams including R&D, clinical affairs, and marketing to support regulatory and QA objectives.
• Ensure that all sales and supply of medicinal products comply with legal requirements:Records pertaining to all phases of drug receipt, supply, storage and distribution are maintained as required by the company and/or legal authorities.

Performs inspections of drug storage area.

Qualifications & requirements:

• Degree in Pharmacy
• Registered with the Singapore Pharmacy Board
• Meticulous and well-organized
• Good communications skills
• Able to work independently
• Ability to meet deadlines
• Proficient in MS Office